Historically, the corrugated box industry has supplied the health care industry with containers for the shipment of hazardous or potentially contaminated materials. Such potentially contaminated materials include such materials as blood and blood products, as well as urine, sputum, body organs, and others. Unfortunately, due to the large volume in this industry and intense price competition, the corrugated box industry has been driven in large part by the need for high speed production and lowering costs.
Because of these pressures on the industry, designs of containers for such materials have been oriented usually toward a single ply corrugated arrangement. For applications requiring greater load bearing capability, primarily in industrial application, a double or triple wall corrugated design was generally accepted as the solution. The multi-wall corrugated design has the advantage of using much the same manufacturing machinery as the single wall design, or may be made in a conversion facility.
In addition to the outer corrugated box container, routine shipping practice includes placing the hazardous material within a primary or inner container. For example, a primary container may comprise a pressure tested screw-top bottle of acceptable construction and durability. Other primary/secondary container combinations are also commonly used, including but not limited to styrofoam. Such primary containers, for example used for whole blood, also include vacutainer rubber stoppered glass or plastic vials.
The standards for packaging performance for the transportation of infectious substances and hazardous materials are established by the United Nations Transport of Dangerous Goods, Chapter 9, as interpreted by the International Maritime Organization ("IMO"), under the Internationals Maritime Dangerous Goods code ("IMDG"), the International Civil Aeronautics Organization ("ICAO"), as interpreted by the International Air Transport Association ("IATA"), the U.S. Department of Transportation ("DOT"), the U.S. Department of Labor's enforcement arm, the Occupational Safety and Hazard Administration ("OSHA"), the U.S. Centers for Disease Control ("CDC"), and other regulatory departments and agencies, domestic and international.
These regulations and guidelines have elevated the requirements to protect the environment and personnel from exposure to the contents of shipping containers, especially materials such as etiologic agents, anti-neoplastic chemicals, acids, caustics, radioactive materials, and related chemicals and product waste streams. The standards generally permit penetration of outer containers by the so-called "Rod Test" and penetration of the primary container or containers by the Rod, provided there is no leakage from the primary container after the tests.
The package performance testing standards for the shipment of infectious substances are specified in the International Air Transport Association Packaging Specifications and Performance Tests, Section 10.5.1 et seq. These tests include, but are not limited to, freezing the first in a series of sample packages to a minimum of 18.degree. C. for up to 24 hours. The first sample package is subjected to the Rod Test. The Rod Test includes a free-fall drop of a 7 kg (15.5 pound), 1.5" diameter steel rod with a 0.2" point onto the top, sides, and bottom of the package from a height of one meter. The Rod Test also includes releasing the pre-packed frozen package in free-fall onto a vertically mounted extended steel spike from a height of one meter.
Performance standards further include a Drop Test. The Drop Test includes freezing a second sample package and subjecting it to a water spray for a, specified duration, then releasing this second sample from approximately nine meters. The present invention has proven to withstand both the Rod Test and the Drop Test.
The container that is the subject of the present invention finds application in clinical laboratories, biological research institutions, and health care organizations that transport specimens from patients and laboratory animals to other laboratory and research locations for diagnostic and scientific evaluation. Laboratory personnel and health care professionals routinely draw blood and other biological specimens into vacuum tubes for scientific and clinical analytical procedures. A substantial volume of such specimens is transported to remote laboratory sites each day, aboard surface transportation and commercial aircraft. The specimens are then handled at each stage of transport by personnel involved in the health care organizations, clinical and research laboratories, surface transportation, commercial aircraft, and airport facilities.
For both convenience and cost, known packaging methods have addressed an environment characterized by relatively low risk to personnel. Hazards presented by the resurgence of infectious diseases, as well as the advent of the AIDS epidemic, justify the packaging which protects personnel and provides a convenient and low cost means of compliance with the standards promulgated by the organizations listed above. Personnel would benefit from the convenience of low cost packaging which is certified for the intended purpose of shipping infectious substances and hazardous materials.
Thus, their remains a need for a high-strength container for the transshipment of hazardous materials. Such a container must protect a primary (inner) container from penetrating impact. The container must also protect the material within the inner container from contamination from materials outside the shipping package. The container must also be adaptable to a variety of sizes and geometries, thus avoiding substantial tooling costs and manufacturing lead-time associated with complex manufacturing techniques, such as injection molding. Also, the container must be adaptable to receive a variety of sizes and configurations of samples and sample containers.